IgY(ΔFc) Antibody-based Turbidimetric Immunoassays (TIA) and Latex-Enhanced Immunoturbidimetric Assays (LETIA or LIT)
The diagnostic reagents Good Biotech Corp. manufactures and offers in the field of in-vitro diagnostics include turbidimetric immunoassays (TIA) and latex-enhanced immunoturbidimetric assays (LETIA or LIT). Manufacturing duck antibodies is the leading-edge technique solely owned by Good Biotech Corp.; duck IgY(ΔFc) antibody, undoubtedly, is used as the major component of the Good Biotech Corp.'s immunochemistry assay kits. TIA is a well-established technique for the rapid quantification of analytes based on antigen-antibody reaction. The measurable range for TIA may be extended by amplifying the immunoaggregate formation obtained by attaching the antibody to latex particles, which is termed a LIT method. Most of the existing TIA/LIT kits are suffering from interferences due to the use of mammalian antibodies. However, for all duck IgY(ΔFc) antibody-based immunochemistry assays produced by Good Biotech, a new type of antibody, duck IgY(ΔFc), has been employed in this test system. Without the Fc domain, IgY(ΔFc) will not cross-react with the following factors which are common interferences for immunoassays:
*Complement *HAMA *Human IgG *RF/ASO *Fc receptors etc
Therefore, duck IgY(ΔFc) antibody is absolutely an ideal choice for developing immunodiagnostics. The sensitivity, precision, and accuracy can be highly improved by using duck IgY(ΔFc) antibody as the material of immunodiagnostic reagents.
The assay kits made from avian IgY(ΔFc) antibodies are superior to those used of mammalian antibodies because:The innovative Duck IgY(ΔFc) Antibody-based TIA/LIT kits developed & produced by Good Biotech Corp. exhibit distinguished characteristics and features include:
TIA & Latex-enhanced TIA(LIT) For automated chemistry analyzers
Good Biotech Corp. has received US FDA 510(k) clearance, CE Marking for its diagnostic products, and has obtained Taiwan- IVD GMP certification for the production of assay kit. Good Biotech has been accredited according to ISO 9001/ ISO 13485 standards, to ensure the consistency and quality of our products from lot to lot.
FDA 510(K) Cleared & ISO 9001/ ISO 13485/ IVD GMP Certified
REF
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CONTENTS (for details click )
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FDA 510(k) No.
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SAMPLE TYPES/ASSAY RANGE |
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KT-0301-W
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Whole Blood (Wide Range CRP): 1.3-230 mg/L
Serum/plasma (Wide Range CRP): 0.6-200 mg/L
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1010
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K020603
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Serum/plasma: 0.05~20 mg/L
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Reactive buffer solution |
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Latex solution |
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1510
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CRPex-HS CRP Calibrator Set |
K021882 |
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2010
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K021757 |
Serum/plasma: 1~300 mg/L
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Reactive buffer solution |
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Latex solution |
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2510
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CRPex-BR CRP Calibrator Set |
K021757 |
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3011
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CRPex CRP Control-L |
K022725 |
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3012
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CRPex CRP Control-M |
K022725 |
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3013
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CRPex CRP Control-H |
K022725 |
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4010
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K050713 |
Serum/plasma: 0.1~200 mg/L
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Reactive buffer solution |
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Latex solution |
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4511
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Duet hs-CRP Calibrator Set |
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KT-0301-D
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K020603
K021757
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High Sensitivity C-Reactive Protein (hs-CRP) Wide Range C-Reactive Protein (wr-CRP)
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VITROS 5,1FS
Reactive buffer solution Latex solution |
Serum
Plasma
Whole Blood*
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HITACHI
Reactive buffer solution Latex solution |
Serum
Plasma
Whole Blood
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5010
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K050576
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Urine: 0~200 mg/L
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Reactive buffer solution |
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Antibody solution |
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5511
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Microalbumin Calibrator Set
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K050576 |
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6011
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Microalbumin Control-L |
K050576 |
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6012
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Microalbumin Control-H
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K050576 |
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7010
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K052617 |
Serum/plasma: 0~1000 ng/ml
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Reactive buffer solution |
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Latex solution |
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7510
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Ferritin Calibrator Set |
K052617 |
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8011
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Ferritin Control-L |
K052617 |
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8012
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Ferritin Control-H |
K052617 |
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KT-0105-A
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K063766 |
Serum/plasma: 0~700 mg/dl
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Reactive buffer solution |
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Antibody solution |
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CA-0105-A
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Transferrin Calibrator Set |
K063766 |
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CL-0105-A
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Transferrin Control-L |
K063766 |
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CL-0105-B
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Transferrin Control-M |
K063766 |
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CL-0105-C
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Transferrin Control-H |
K063766 |
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KT-0202-A
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(Beta-2-Microgloblin) |
Serum: 0.1~20 mg/L
Urine: 0.01~8 mg/L
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Reactive buffer solution |
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Latex solution |
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CA-0202-A
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B2M Calibrator Set
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CL-0202-A
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B2M Control-L
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CL-0202-B
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B2M Control-M
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CL-0202-C
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B2M Control-H
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Contact partnership@good-biotech.com for more information and a chance to work together in a mutually beneficial association.
"Standardization of Immunoassays for Measurement of High-Sensitivity C-reactive Protein. Phase I: Evaluation of Secondary Reference Materials"
(Clinical Chemistry)
Good Biotech was invited by the author (Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, US) to participate in this hsCRP project and is also one of the Latex-enhanced Immunoturbidimetry Assay manufacturers invited.
Below are some of the Published Papers using Good Biotech's High-sensitivity C-reactive protein (hs-CRP) Assay Kit:
“Circulating CD40 ligand is elevated only in patients with more advanced symptomatic peripheral arterial diseases”
"Coronary artery disease progression is associated with C-reactive protein and conventional risk factors but not soluble CD40 ligand"
The Canadian Journal of Cardiology (CJC)
"The short-/intermediate-term changes in novel vascular inflammatory markers after angioplasty plus stenting in patients with symptomatic advanced systemic arterial diseases"
“Simvastatin reduces plasma concentration of high-sensitivity C-reactive protein in type 2 diabetic patients with hyperlipidemia”
Journal of Diabetes and its Complications
"C-reactive protein and risk factors for peripheral vascular disease in subjects with Type 2 diabetes mellitus"
"C-Graves' disease presented as painful goiter"